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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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AI Applications for 5 Different Legal Fields

LawTechnologyToday

Artificial intelligence (AI) is one of the most revolutionary technologies ever to enter the business world. While legal professionals have been slower to embrace this technology, AI for lawyers is a growing field. Legal firms spent approximately $12 billion on AI in 2017, and experts expect that figure to reach $85 billion by 2027.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Highlights from FDA’s Draft MDUFA V Commitment Letter

FDA Law Blog

MDUFA V would be applicable to fiscal years 2023 through 2027. FDA published in the Federal Register a draft version of its MDUFA V commitment letter , which outlines FDA’s updated performance goals in reviewing device applications and planned process improvements.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website. Earlier this year, FDA published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (DHT Framework).

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. FDA acknowledges that such data offer opportunities to generate evidence and better understand clinical outcomes.

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Why Legal Process Outsourcing is the right choice for you?

Cenza

Other challenges include cybersecurity concerns, difficulties with remote work, process workflow optimization, and the adoption of new technology. The global legal process outsourcing (LPO) market, which is predicted to reach US$30 billion by 2027 , has surged as a result of this influence. Industry Trends for LPO.